%0 Journal Article
%A Rossello, Xavier
%A Rodriguez-Sinovas, Antonio
%A Vilahur, Gemma
%A Crisóstomo, Verónica
%A Jorge, Inmaculada
%A Zaragoza, Carlos
%A Zamorano, José L
%A Bermejo, Javier
%A Ordoñez, Antonio
%A Boscá, Lisardo
%A Vázquez, Jesús
%A Badimón, Lina
%A Sánchez-Margallo, Francisco M
%A Fernández-Avilés, Francisco
%A Garcia-Dorado, David
%A Ibanez, Borja
%T CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions.
%D 2019
%U http://hdl.handle.net/10668/14905
%X Despite many cardioprotective interventions have shown to protect the heart against ischemia/reperfusion injury in the experimental setting, only few of them have succeeded in translating their findings into positive proof-of-concept clinical trials. Controversial and inconsistent experimental and clinical evidence supports the urgency of a disruptive paradigm shift for testing cardioprotective therapies. There is a need to evaluate experimental reproducibility before stepping into the clinical arena. The CIBERCV (acronym for Spanish network-center for cardiovascular biomedical research) has set up the "Cardioprotection Large Animal Platform" (CIBER-CLAP) to perform experimental studies testing the efficacy and reproducibility of promising cardioprotective interventions based on a pre-specified design and protocols, randomization, blinding assessment and other robust methodological features. Our first randomized, control-group, open-label blinded endpoint experimental trial assessing local ischemic preconditioning (IPC) in a pig model of acute myocardial infarction (n = 87) will be carried out in three separate sets of experiments performed in parallel by three laboratories. Each set aims to assess: (A) CMR-based outcomes; (B) histopathological-based outcomes; and (C) protein-based outcomes. Three core labs will assess outcomes in a blinded fashion (CMR imaging, histopathology and proteomics) and 2 methodological core labs will conduct the randomization and statistical analysis.
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